We can’t predict the next big emerging infectious disease epidemic, but University of Florida researchers are working to develop innovative vaccine study designs so that agencies can implement vaccine trials quickly and effectively in the event of an outbreak.
The work is supported by a five-year $3.5 million grant from the National Institute of Allergy and Infectious Diseases. The project is part of the Modeling of Infectious Disease Agent Study, or MIDAS, a network of infectious disease modelers operated by the National Institute of General Medical Sciences.
“Our goal is to provide the research community with flexible and innovative approaches for evaluating vaccine efficacy that are tailored to the increased uncertainty inherent in infectious disease outbreaks,” said lead investigator Natalie Dean, Ph.D., an assistant professor in the department of biostatistics at the UF College of Public Health and Health Professions and the UF College of Medicine.
The research team will focus on the priority diseases identified by the World Health Organization Research and Development Blueprint for Action to Prevent Epidemics for their likelihood to cause public health emergencies. The list currently includes Zika, Lassa fever, Crimean Congo Hemorrhagic fever (CCHF), Middle East Respiratory Syndrome (MERS), Ebola, Marburg, Severe Acute Respiratory Syndrome (SARS), Nipah, Rift Valley Fever (RVF), and Disease X, otherwise known as a future unknown threat.
Members of the team were involved in the design of the successful Ebola vaccine trial in Guinea in 2014, which used an innovative ring vaccination strategy.
Study aims include constructing a class of responsive vaccine trial designs in which recruitment and/or vaccination is triggered by local transmission; designing strategies for combining information across outbreaks; and developing adaptive, multi-arm and observational study designs.
“The output of our research will be a set of designs and associated analytical methods that are rigorous to the level that they can be used in vaccine licensure decisions,” Dr. Dean said. “The research will also produce the computational models and strategies that serve as a basis for tailoring these designs to future outbreaks.”
In addition to Dean, the study team includes UF biostatistics faculty members Ira Longini, Ph.D., Yang Yang, Ph.D., and Samuel Wu, Ph.D.; M. Elizabeth Halloran, DSc, of Fred Hutchinson Cancer Research Center and the University of Washington; and Alex Vespignani, Ph.D., and Marco Ajelli, Ph.D., of Northeastern University.